Phase 2 N=12 Treatment

Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies

Acute Lymphoblastic Leukemia (ALL) · Acute Myelogenous Leukemia (AML) · Myelodysplastic Syndrome (MDS) · Non-Hodgkin's Lymphoma · Hodgkin's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01221857 ↗

Enrolled (actual)

Serious AEs

66.7%

Results posted

Feb 2019

Primary outcome: Primary: Acute Toxicity Associated With the Infusion of NiCord — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: NiCord® (Drug)
Age: Pediatric, Adult, Older Adult · 8+ yrs
Sex: All
Sponsor: Gamida Cell ltd
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Acute Toxicity Associated With the Infusion of NiCord	—	—
PRIMARY Proportion of Patients With Neutrophil Engraftment	0.91	—
SECONDARY Proportion of Patients Who Developed Acute GvHD Grade II-IV and III-IV	0.45; 0	—
SECONDARY Non-relapse Mortality	0.09	—

Summary

Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second, Unmanipulated CBU in Patients with Hematological Malignancies

Eligibility Criteria

Inclusion Criteria

Applicable disease and eligible for myeloablative SCT
Patients must have two partially HLA-matched CBUs
Back-up stem cell source
Adequate Karnofsky Performance score or Lansky Play-Performance scale
Sufficient physiological reserves
Signed written informed consent

Exclusion Criteria

HLA-matched related donor able to donate
Prior allogeneic HSCT
Lymphoma patients with progressive disease
Other active malignancy
Human immunodeficiency virus (HIV) infection
Active or uncontrolled infection
Active/symptoms of central nervous system (CNS) disease
Pregnancy or lactation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01221857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.